SYQUET

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

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Bipacksedel Bipacksedel (PIL)
24-05-2024
Produktens egenskaper Produktens egenskaper (SPC)
24-05-2024

Aktiva substanser:

Quetiapine fumarate

Tillgänglig från:

Dr Reddy's Laboratories Australia Pty Ltd

Klass:

Medicine Registered

Bipacksedel

                                SYQUET 
_Quetiapine fumarate _
_________________________________________________________________________________ _
_ _
CONSUMER MEDICINE INFORMATION
 
 
WHAT IS IN THIS LEAFLET 
 
This leaflet answers some 
of the common questions 
people ask about Syquet. 
It does not contain all the 
available information. 
 
It does not take the place 
of talking to your doctor or 
pharmacist. 
 
All medicines have risks 
and benefits. Your doctor 
will have weighed the 
risks of you taking  it 
against the benefits they 
expect it will have for you. 
 
IF YOU HAVE ANY 
CONCERNS ABOUT TAKING 
THIS MEDICINE, ASK YOUR 
DOCTOR OR PHARMACIST. 
 
KEEP THIS LEAFLET WITH 
THE MEDICINE.  
 
You may need to read it 
again. 
 
WHAT SYQUET IS USED 
FOR 
 
Syquet helps to correct 
chemical imbalances in 
the brain. It is used to 
treat conditions such as: 
 
 Schizophrenia, 
an 
illness with 
disturbances in 
thinking, feelings and 
behaviour 
  Bipolar disorder, an 
illness in which there 
are sustained mood 
swings either up 
(mania) or down 
(depression). During 
mania patients 
experience episodes 
of overactivity, elation 
or irritability. During 
depression, patients 
may feel depressed or 
guilty, lack energy, 
lose their appetite and 
have trouble sleeping. 
 
Syquet belongs to a 
group of medicines called 
antipsychotics.  
 
ASK YOUR DOCTOR IF YOU 
HAVE ANY QUESTIONS 
ABOUT WHY IT HAS BEEN 
PRESCRIBED FOR YOU. 
 
Your doctor may 
prescribe this medicine 
for another reason.  
 It is not addictive. 
 
This medicine is available 
only with a doctor's 
prescription. 
 
BEFORE YOU TAKE IT 
 
_WHEN YOU MUST NOT TAKE _
_IT _
_ _
DO NOT TAKE SYQUET IF 
YOU HAVE AN ALLERGY TO  
 
  quetiapine, the active 
ingredient in the 
medicine 
   any of the other 
ingredients listed at 
the end of this leaflet. 
 
Some of the symptoms of 
an allergic reaction may 
include shortness of 
breath, wheezing or 
difficulty b
                                
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Produktens egenskaper

                                SYQUET FILM COATED TABLETS 
 
PRODUCT INFORMATION 
 
 
NAME OF THE MEDICINE 
Quetiapine fumarate 
 
Chemical name: bis[2-(2- [4-(dibenzo[b,f][1 ,4] -thiazepin-11-yl)
piperazin-1-yl] 
ethoxy) ethanol] fumarate.  
Quetiapine fumarate has no chiral centres and
only one morphological entity has 
been detected throughout development. 
_Structural Formula: _
 
 
CAS: 111974-72-2 
 
DESCRIPTION 
Quetiapine fumarate is a weak acid (pKa 3.3, 6.8) which exhibits
moderate pH 
dependent solubility (94.3 to 2.37 mg/mL at pH values from
1 to 9) and 
lipophilicity characteristics (log P) which
vary with pH (0.45 in water, 1.37 at pH 5, 
2.65 at pH 7 and 2.59 at pH 9). 
Quetiapine fumarate displays good solid state stability, has
an aqueous solubility of 
3.29 mg/mL at 25°C and exhibits suitable tableting properties when combined with 
appropriate excipients. 
Quetipapine-DRLA 25 mg, 100 mg, 200 mg, and 300 mg tablets
contain 
quetiapine fumarate equivalent to 25 mg, 100
mg, 200 mg, and 300 mg quetiapine 
free base respectively. 
 
 
 
 
_EXCIPIENTS _
 povidone, calcium hydrogen phosphate, cellulose -
microcrystalline, 
lactose, sodium starch glycollate, silica - colloidal anhydrous, magnesium stearate, 
hypromellose, macrogol 400, titanium dioxide, iron
oxide yellow CI 77492 (25, 100) 
and iron oxide red CI 77491 (25 mg) 
 
PHARMACOLOGY 
MECHANISM OF ACTION
  
Quetiapine is an atypical antipsychotic agent. Quetiapine
and the human plasma 
metabolite, norquetiapine, interact with a broad
range of neurotransmitter 
_ _
Product Information_v02 
Page 2 of 37 
receptors. Quetiapine and norquetiapine exhibit affinity
for brain serotonin (5HT
2
) 
and dopamine D
1
 and D
2
 -receptors; this combination of receptor antagonism 
with a higher selectivity for 5HT
2
 relative to D
2
 -receptors is believed to contribute 
to the clinical antipsycho
                                
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